Immulite Acth
FDA 510(k) K960066 · Diagnostic Products Corp.
510(k) numberK960066
Submission
- Device name
- Immulite Acth
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- January 5, 1996
- Decision date
- February 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CKG – Radioimmunoassay, Acth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1025
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K223867 | Ids Acth IICKG · Traditional | Immunodiagnostic Systems Limited | 08/18/2023SE |
| K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321CKG · Traditional | Tosoh Bioscience, Inc. | 12/01/2011SE |
| K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhCKG · Traditional | Roche Diagnostics Corp. | 05/03/2006SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | Scantibodies Laboratory, Inc. | 05/20/2005SE |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | Scantibodies Laboratory, Inc. | 06/03/2002SE |
| K002638 | Future Diagnostics B.V. Stat-Acth KitCKG · Traditional | Future Diagnostics B.V. | 01/17/2001SE |
| K982608 | Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitCKG · Traditional | Sangui Biotech, Inc. | 08/19/1998SE |
| K962601 | Nichols Advantage Chemiluminescence Adrenocorticotropic HormoneCKG · Traditional | Nichols Institute Diagnostics | 12/24/1996SE |
| K960491 | Micro Haematocrit CentrifugeCKG · Traditional | Hawksley & Sons , Ltd. | 10/18/1996SE |
| K940271 | Incstar Acth IrmaCKG · Traditional | Incstar Corp. | 08/02/1994SE |
More from Incstar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Acth cleared by the FDA?
Immulite Acth (K960066) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 42 days after the submission was received.
What is the product code of K960066?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.